Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01318694
Eligibility Criteria:
Inclusion criteria:
* Chronic HCV infection
* HCV genotype 1
* No previous treatment for hepatitis C infection
* Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
* Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months
Exclusion criteria:
* HCV genotype different from genotype 1 or co-infection with other HCV genotype
* Co-infection with Hepatitis B or HIV
* Any other cause of relevant liver disease other than HCV
* Presence or history of hepatic decompensation
* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\> ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01318694
Study Brief:
Protocol Section:
NCT01318694